Decentralized Clinical Trials Among Topics Slated For CDER Guidance In 2020
US FDA's to-do list also includes guidances on development of non-opioid analgesics and cannabis compounds, evaluation of generic therapeutic equivalence, and pediatric product development.
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Work on guidance that was originally expected in 2020 continues as the agency and industry learn more about the utility and spectrum of decentralized trials as a result of the novel coronavirus pandemic.
While companies often keep clinical trial endpoints a secret, FDA's Peter Marks notes that may not be the case with COVID-19 vaccines; CDER's Patrizia Cavazzoni says agency may expand de-centralized trials.
The agency offers a glimpse of its regulatory agenda, although several have been carried over through multiple list updates.